Fornix manipulator

ABSTRACT

A fornix manipulator includes a collar and stabilizer. The collar has a first end and a second end, the second end having an opening and diameter greater than the first end and the first end having an opening to receive a cervix into the collar. The stabilizer has a base portion defining a guide hole and a plurality of prongs extending from the base portion to contact the first end of the collar.

CROSS-REFERENCE TO RELATED APPLICATIONS

This U.S. non-provisional patent application claims priority under 35U.S.C. §119 of U.S. Provisional Application No. 61/326,326, filed onApr. 21, 2010, the entire contents of which are hereby incorporated byreference.

BACKGROUND

1. Field of the Invention

The present disclosure relates to a formix manipulator, and moreparticularly, to a device that delineates and deviates the vaginalformix while preserving access to the cervix and supporting the vaginalwall to create a platform or plane for dissection.

2. Description of the Related Art

In some medical procedures, the vaginal formix may need to be delineatedand/or deviated away from other vital organs. In addition, the formixand neighboring vaginal wall may need to be supported to provide aplatform or plane for dissection. Many medical procedures requiremanipulation of the formix. These include but are not limited to:hysterectomies; colpotomies; vaginal suspensions; colpoplexies; andresections of vesicovaginal fistulas, pelvic endometriesis, cancer,fibroids, and adhesions.

For example, in a hysterectomy, a surgeon cuts through the vaginalformix to detach and remove the cervix and uterus from the body. Here,the vaginal formix must be precisely delineated to prevent injury to thevaginal wall and neighboring vital organs, such as the bladder, bowel,or ureters. In addition to delineating the formix, the surgeon may alsohave to deviate or move the formix away from vital organs duringincision. If organs are connected to the vaginal wall or formix, thesurgeon may also have to dissect or cut the connecting tissue. Thisrequires supporting the formix and vaginal wall together to provide anadequate platform or plane for dissection.

FIG. 1A-C illustrate the location of the formix. FIG. 1A is a sagittalcross-section of a female pelvis. The cervix 103 opens into the uterus104, and the ovaries 105 are connected to the uterus 104. On one side ofthe vagina 107, toward the front of the body, is a bladder 112 and aurethra 106 leading from the bladder to an outside of the body. Onanother side of the vagina 107, toward the rear of the body, is therectum 109 between intestines 110 and the anus 108 which opens from therectum 109 to outside the body.

FIG. 1B is a view of the cervix 103 from the vaginal canal. FIG. 1C is asimplified view of the uterus 104 from within the abdomen 111. Surgeonsmay access the uterus 104 and other organs from the abdominal cavity111.

The formix 100 is a cylindrical ring of tissue encircling the cervix 103and lower uterus 104. The lowest cylindrical ring is the intra-vaginalformix 101, The intra-vaginal formix 101 encircles the cervix 103 and isvisible from the vaginal canal, as illustrated by FIG. 1B. Theintra-vaginal formix 101 is located between the vaginal wall 102 and thecervix 103, as illustrated by FIGS. 1A and 1B.

The upper-most cylindrical ring of the formix 100 is the intra-abdominalformix 113. When viewed from the abdomen, as in FIG. 1C, the anteriorhalf of the intra-abdominal formix 113 may be visible, but it is neitherdemarcated nor obvious to the human eye. It is therefore indicated witha dotted line. The ring of the intra-abdominal formix 113 passes betweenthe uterus 104 and rectum 109, and also passes between the uterus 104and bladder 112, as indicated by FIG. 1.

The length of the formix 100, or the distance between the lowest andupper-most cylindrical rings (i.e. the intra-vaginal formix 101 andintra-abdominal formix 113, respectively) is indicated by dotted linesin FIG. 1.

Several problems and injuries may result when using conventionaldevices, known as uterine manipulators, to manipulate the formix 100.These problems include imprecise formix delineation and deviation;vaginal shortening; and abdominal deflation. Injury can also result fromblocked cervical access and blind cervical retrieval; device insertionand retrieval; and lack of a platform while dissecting vital organs awayfrom the formix and vaginal wall.

FIGS. 2A and 2B illustrate a first conventional device to performuterine manipulation, and FIG. 3 illustrates a second conventionaldevice. In the first conventional device 210, a first cup 211 has afirst end 213 positioned at or near the intra-vaginal formix 101. Thesecond device 310 has a similar shape, with a single cup 311 having afirst end 313 positioned at or near the intra-vaginal formix 101. Whenpressure is applied against cups 211 or 311, their respective first ends213 and 313 push the intra-vaginal formix 101 against theintra-abdominal formix 113. Eventually, the first end bulges through theformix 100 into the abdomen as a distended ring of formix tissue. Thebulging ring formed by the first ends delineates the circumference ofthe formix 100 when viewed from the abdomen.

Conventional devices may misestimate the location and diameter of thevaginal formix 100, causing inaccurate delineation. The diameter of thefirst ends 213 and 313 of devices 210 and 310, respectively, may begreater than the diameter of the intra-vaginal formix 101. Here, firstends 213 and 313 do not delineate the intra-vaginal formix 101, but theupper third of the vaginal wall 102. In addition, the length of thecervix may be greater than the depths of the cups 211 and 311,respectively. Here, first ends 213 and 313 would not delineate theintra-vaginal formix 101, since the length of the cervix 103 wouldprevent the ends 213 and 313 from reaching the intra-vaginal formix 101.Rather, the devices would delineate the upper third of the vaginal wall.

When conventional devices misestimate the location and diameter of thevaginal formix 100, the surgeon cannot precisely deviate the formix awayfrom other vital organs when operating inside the abdomen 111.

Inaccurate delineation can also lead to vaginal shortening. If a surgeonseeks to cut through the circumference of the formix 100, the inaccuratedelineation may cause the surgeon to cut through the vaginal wall 102,instead of in the formix 100 itself. When a surgeon cuts the vaginalwall instead of the formix 100, the length of the vaginal canaldecreases.

Conventional uterine manipulators are also ill-suited for laparascopicand robotic surgeries that require abdominal inflation, also known asinflation of the peritoneal cavity. In laparoscopic and roboticsurgeries, a camera and surgical tools are inserted through a navel portor small incisions on the lower abdomen. A constant supply of air or gasis pumped into the abdomen to inflate the abdomen. The inflated abdomencreates space for the surgeon to maneuver the camera and instrumentswithout injuring vital organs. However, when a surgeon makes an incisionthrough the vaginal formix, gas escapes from the abdomen through thevaginal canal. When the air leaks out, the abdomen disinflates, makingit difficult to maneuver instruments and increasing the risk of organinjury.

Conventional uterine manipulators do not prevent abdominal disinflation.Rather, incised tissue retracts from the point of the incision andcreates a hole or space between the device and tissue for air to escape.In the first device 210, since the first end 213 of the first cup 211has a diameter greater than the second end 214, the tissue of thevaginal wall 102 retracts from the incision at the first end 213 towardthe second end 214. A space forms between the vaginal wall 102 and firstdevice 210. Consequently, air escapes from the abdominal cavity 111. Thesecond device 310 attempts to prevent air leakage by inflating a balloon312 within the vagina 107. However, air may continue to leak, and at thesame time, the cervix 103 cannot be accessed from the vagina 107.

Conventional uterine manipulators block access to the cervix from thevagina 107. For example, the first device 210 blocks access to thecervix 103 with both the first and second cups 211 and 212, and thesecond device 310 blocks access to the cervix 103 with the balloon 312.Consequently, if the cervix 103 and attached uterus 104 must beretrieved from the vagina 107 after a hysterectomy, the surgeon mustfirst remove the uterine manipulator and then reach into the vagina 107to blindly feel around for the cervix 103. At times, the surgeon pullsand tears the incised formix 100 or vaginal wall 102. In roboticoperations in particular, this may add significant time to theprocedure, since it requires the surgeon to scrub before reaching in.

Conventional uterine manipulators pose injury risks in removal. Forexample, the cups 211, 212, and 311 may get stuck in the vaginal canalwhen the uterine manipulator 230 or 330 is extracted from the vagina107. This may occur since the diameter of the cups may be larger than adiameter of the vaginal opening. To retrieve the cups, the surgeons mustblindly reach and fish for the cups. At times, the surgeon may pull anddamage tissue, or the surgeon may have cut the vaginal opening to removethe cups.

Conventional uterine manipulators also pose injury risks upon insertion.Since the devices are of predetermined diameters with the first endlarger than the second end, the tissue of the vaginal wall 102 may bedamaged when the vagina 107 has a smaller diameter than the diameters ofthe first ends of devices 210 and 310.

Conventional uterine manipulators do not provide a platform or plane fordissection. For example, when performing a hysterectomy, the surgeon mayneed to dissect vital organs such as the bladder 112 and the rectum 109away from the vaginal wall. These vital organs are connected to thevaginal wall 102 and at times the formix 100. Thus, heat fromcauterizing the formix 100 may travel through the tissue and injure thethese organs if not dissected away. In the first device 210, cups 211and 212 become narrower at their intersection 210, and therefore do notprovide a surface or plane on which to perform a dissection. The seconddevice 310 likewise does not provide a surface for dissection sincethere are spaces or holes in cup 312. The lack of a platform or evenplane increases the risk of injury to vital organs in hysterectomies aswell as other operations that require resections, such as operations toremove endometriosis, cancer, fibroids, pelvic adhesions, andvesicovaginal fistulas.

SUMMARY

The present general inventive concept relates to a formix manipulatorwhich includes a collar and a stabilizer. The formix manipulatoraddresses the above-described problems, including imprecise formixdelineation and deviation; vaginal shortening; abdominal deflation;blocked cervical access; and unnecessary tissue damage from blindcervical retrieval, device insertion and retrieval, and lack of aplatform for organ dissection. However, the present general inventiveconcept is not limited to addressing only the above-described problems,and other benefits, features, and/or utilities of the present generalinventive concept may be apparent to one of ordinary skill in the art.

Features of the present general inventive concept may be realized by acollar having a first end and a second end having a diameter greaterthan the first end, the first end having a first opening to receive acervix into the collar and a rim to encircle the opening, and the secondend having a second opening, the collar having an inner surface andouter surface, wherein the outer surface is in contact with the vaginalwall, and a stabilizer comprising a base portion and a plurality ofprongs extending from the base portion into the second end of thecollar, wherein the ends of the prongs contact the collar.

The ends of the prongs may contact an inner surface of the first end ofthe collar.

The collar may have one of a trapezoid cross-section shape, a domedcross-section shape, or a combination of a trapezoid and domedcross-section shape.

The collar may have a plurality of parallel ridges around an outersurface of the collar.

The collar may have one of a hole, ring, tab, or other protrusion fixedto the collar to receive a strap.

The rim may include an outer edge, an inner edge, and a rim surfacebetween the outer edge and the inner edge to define the opening, and therim surface is angled with respect to a plane defined by the outer edge.

The rim may include a protrusion extending inward toward a middleportion of the collar from the first end.

The collar rim may include a first outer rim edge adjacent to the firstopening and a second outer rim edge separated from the first outer rimedge by a gully.

The ends of the prongs may contact a trough on the inner surface betweenthe second outer rim edge and collar wall.

The base portion of the stabilizer may have a guide hole.

The ends of the prongs of the stabilizer may contact a rim on the innersurface of the first end of the collar.

The stabilizer may include a stabilizer rim connecting the ends of theprongs that are opposite the base portion.

The stabilizer rim may contact an inner surface of the first end.

The stabilizer rim may contact a rim on the inner surface of the firstend.

The stabilizer rim may contact a trough on the inner surface between thesecond outer rim edge and collar wall.

The stabilizer rim may include an outer edge, an inner edge, and a rimsurface between the outer edge and the inner edge to define the opening,and the rim surface is angled with respect to a plane defined by theouter edge.

The stabilizer rim may include an inner edge, an outer edge that iscloser than the inner edge to the base portion in a linear direction andfarther from a center of the stabilizer in a radial direction than theinner edge, and an outer rim surface that connects the inner edge to theouter edge.

A diameter of the inner edge of the stabilizer rim is smaller than adiameter of the collar rim, such that a gap is located between the inneredge of the stabilizer rim and the collar rim when the outer edge of thestabilizer is in contact with the inner surface of the first end of thecollar.

The inner edge of the stabilizer rim may extend past the collar rim in alinear direction when the outer edge of the stabilizer is in contactwith the inner surface of the first end of the collar.

The inner edge of the stabilizer rim may be flush with the collar rimwhen the outer edge of the stabilizer is in contact with the innersurface of the first end of the collar.

Features of the present general inventive concept may also be realizedby a collar, including a first end including a rim to define a firstopening, the first end having a first diameter, a second end having asecond opening and having a second diameter greater than the firstdiameter, and a side wall between the first end and the second end todefine an inner cavity between the first opening and the second opening,wherein the first diameter is such that a cervix of a predeterminedsecond diameter slides into the first opening and is located in thecavity.

The rim of the first end may circumscribe a vaginal formix.

The collar may have one of a trapezoid cross-section shape, a domedcross-section shape, or a combination of a trapezoid and domedcross-section shape.

The collar may include a plurality of parallel ridges located around anoutside surface of the side wall.

The collar may have one of a hole, ring, tab, or other protrusion fixedto the collar to receive a strap.

The rim may include a first outer rim edge adjacent to the first openingand a second outer rim edge separated from the first outer rim by agully.

The rim may include a protrusion extending inward toward the innercavity from the first end.

The rim may include an outer edge, an inner edge, and a rim surfacebetween the outer edge and the inner edge to define the opening, and therim surface is angled with respect to a plane defined by the outer edge.

The rim surface may have one of a concave and a convex shape.

Features of the present general inventive concept may also be realizedby a stabilizer to contact one of a rim or ring encircling a cervix, thestabilizer including a plurality of prongs extending from a base portionto contact the one of a rim or ring.

The stabilizer of claim 30, wherein the base portion has a guide hole.

The ends of the prongs may include one of a protrusion and a notch tolatch a respective notch or protrusion of one of a rim or ring toconnect to the rim or ring.

The ends of the plurality of prongs opposite the base portion may beconnected by a rim.

The stabilizer rim may have a surface to contact a surface of one of arim or ring.

The stabilizer rim may include an outer edge, an inner edge, and a rimsurface between the outer edge and the inner edge to define the opening,and the rim surface is angled with respect to a plane defined by theouter edge.

The rim surface may be one of a concave or convex shape.

The stabilizer rim may include an inner edge, an outer edge that iscloser than the inner edge to the base portion in a linear direction andfarther from a center of the stabilizer than the inner edge in a radialdirection, and an outer rim surface that connects the inner edge to theouter edge.

The outer rim surface may be concave-shaped.

The prongs may extend from the base portion to form one of a “U” shape,a “V” shape, or a wishbone shape, with the base portion located at acenter point of the “U,” the “V”, and the wishbone, respectively.

Ends of the plurality of prongs opposite the base portion may not bemechanically connected to each other.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of the general inventive concept and are incorporated inand constitute a part of this specification. The drawings illustrateexemplary embodiments of the general inventive concept and, togetherwith the description, serve to explain principles of the generalinventive concept.

FIGS. 1A-C illustrate a basic anatomy around the cervix, uterus, andvagina. FIG. 1A illustrates a sagittal cross-section of a female pelvis.FIG. 1B is a view of the cervix 103 from the vaginal canal. FIG. 1C is aview of the uterus 104 from within the abdomen 111.

FIGS. 2A and 2B illustrate an example of a conventional device used toperform operations and procedures relating to the vaginal formix.

FIG. 3 illustrates another example of a conventional device used toperform operations and procedures relating to the vaginal formix.

FIG. 4 illustrates placement of a formix manipulator within a vaginalcanal.

FIGS. 5A and 5B illustrate shapes of the formix manipulator's collar.

FIGS. 6A to 6D illustrate cross-section views of the collar.

FIGS. 7A to 7C illustrate an angle of the rim of the collar or,alternatively, (if a rim connects the prongs of a stabilizer), the rimof a stabilizer.

FIGS. 8A to 8F illustrate views of a collar according to an embodimentof the general inventive concept including a gully or trough between anouter rim and an inner rim.

FIGS. 9A to 9C illustrate varied shapes of the prongs in relation to thebase of the formix manipulator.

FIGS. 10A to 10C illustrate varied configurations of prongs of theformix manipulator.

FIGS. 11A to 11C illustrate operation of the stabilizer and the collaraccording to embodiments of the general inventive concept.

FIG. 12 illustrates a shape of the end portions of the stabilizer'sprongs.

FIGS. 13A to 13D illustrate inner ridges of the collar.

FIGS. 14A and 14B illustrate a stabilizer according to anotherembodiment of the present general inventive concept.

FIGS. 15A to 15D illustrate a relationship between a prong and a rim ofa stabilizer.

FIG. 16 illustrates a stabilizer having a rim positioned within acollar.

FIGS. 17A to 17D illustrate a stabilizer according to another embodimentof the present general inventive concept having a protruding rim.

FIGS. 18A and 18B illustrate a strap connection of a collar according toan embodiment of the present general inventive concept.

FIG. 19 illustrates a formix manipulator when used in conjunction withto a uterine shaft device.

FIGS. 20A and 20B illustrate a collar with ridges.

DETAILED DESCRIPTION OF THE EMBODIMENTS

Preferred embodiments of the general inventive concept will be describedbelow in more detail with reference to the accompanying drawings. Theembodiments of the general inventive concept may, however, be embodiedin different forms and should not be constructed as limited to theembodiments set forth herein. Rather, these embodiments are provided sothat this disclosure will be thorough and complete, and will fullyconvey the scope of the general inventive concept to those skilled inthe art. Like numbers refer to like elements throughout.

FIG. 4 illustrates a formix manipulator composed of a collar 10 and acollar stabilizer 20 in operation inside a vaginal canal. The collar 10and the stabilizer 20 may slide onto a uterine shaft 30 and be insertedinto the vagina 107. A contact end of the collar 10 may slide over thecervix 103 and be pressed in contact with the intra-vaginal formix 101surrounding the cervix 103. Pressure against the stabilizer 20 causesthe contact end of the collar 10 to further press against theintra-vaginal formix 101, causing the formix 100 to distend into theabdomen and producing a bulge visible on the intra-abdominal formix 113.This bulge delineates the formix 100 for incision. A uterine shaftlocking screw may lock the stabilizer in place to maintain pressureagainst the intra-vaginal formix 101 and preserve delineation. Anincision may be made in the abdomen and medical instruments, such asscalpels, cameras, or any other medical instruments may be introducedinto the abdominal cavity 111. The formix 100 may be incised by cuttingthe delineating bulge on the distended intra-abdominal formix 113. Theformix 100 may also be deviated by moving the shaft attached to thestabilizer 20 and collar 10. In addition, the dome wall 14 of the collar10 may provide a platform for dissection of vital organs and tissue fromthe vaginal wall 102.

Operation of the collar 10 with respect to the cervix 103, vaginalformix 100, and other tissues will be described in greater detail below.

FIGS. 5A and 5B illustrate a shape of the collar 10 according toembodiments of the general inventive concept. As illustrated in FIG. 5A,the collar 10 a includes a contact end 11 and a receiving end 12. A sidewall 14 defines a profile of the collar 10 a. The collar 10 may have atrapezoidal profile, as illustrated in FIG. 2A, a dome-shaped profile,as illustrated by the collar 10 b of FIG. 2B, or any other appropriateshape to define and support the vaginal wall. For example, the sidewalls 14 may have a straight line shape, a convex shape, or anycombination of the two shapes. Side wall 14 expands the vaginal canaland provides a platform or plane for dissecting vital organs away fromthe vaginal wall 102. Organs such as the bladder, ureters, rectum andbowel are protected from heat produced by cauterization of the formix100. This is particularly important in procedures such ashysterectomies; colpotomies; vaginal suspensions; colpoplexies; andresections of vesicovaginal fistulas, pelvic endometriesis, cancer,fibroids, and adhesions.

In addition to providing a platform for dissection, the dome ortrapezoidal shape of the collar is critical to solving the problem ofabdominal disinflation. The increasing diameter of the collar 10 makesit difficult for the tissue to retract from the contact end 11 to thereceiving end 12. In conventional devices, the diameter decreases,allowing the tissue to retract back easily since the diameter of theincision exceeds the diameter of the cup edge used to delineate theincision.

In addition, the increasing diameter of the collar 10 minimizes the riskof vaginal injury upon insertion of the device to the vaginal canal. Incontrast to conventional devices that insert largest diameter end first,the formix manipulator inserts the smallest diameter end first, therebyallowing the vaginal opening to expand to the larger diameter as thedevice is inserted.

The collar 10 may be made of semi-rigid or rigid material that does notchange in shape in response to a force from the stabilizer 20 or anyother device. This allows the collar 10 to serve as an adequate platformfor dissection and allows it to delineate the formix 100 with precision.However, the material may be semi-rigid to allow compression of theouter end 12 when removing the device from the vaginal canal after themedical procedure.

FIG. 6A illustrates a cross-section view of the collar 10 according toan embodiment of the present general inventive concept. The side wall 14of the collar 10 defines an opening 11 a of the contact end 11 andanother opening 12 a in the receiving end 12. The side wall 14 maydefine a cavity or hollow tunnel 19 between the openings 11 a and 12 a.The opening 11 a may be defined by a rim 13 having an outer edge 13 a,an inner edge 13 b, and a rim surface 13 c between the outer and inneredges 13 a and 13 b. The outer surface of the rim 13 may define an outerrim surface 13 d surrounding the opening 11 a. The inner surface of therim 13 opposite the outer rim surface 13 d may define an inner rimsurface 13 e. The rim surface 13 c may be formed at an angle withrespect to a plane defined by the outer edge 13 a or the outer rimsurface 13 d.

As illustrated in FIG. 6A, the rim surface 13 c may have a substantiallyflat or planar surface. FIGS. 6C and 6D illustrate alternativeembodiments of the rim surface 13 c. In FIG. 6C, the rim surface 13 chas a concave shape, so that a center portion of the rim surface 13 c iscurved inward with respect to the outer rim 13 a and the inner rim 13 b.FIG. 6D illustrates a rim surface 13 c having a convex shape, so thatthe center portion of the rim surface 13 c is curved outward withrespect to the outer rim 13 a and the inner rim 13 b.

FIG. 6B illustrates the placement of the collar 10 (which includes ahollow tunnel 19) with respect to the cervix 103. The rim 13 of thecollar 10 may be placed around the outside of the cervix 103, so thatthe outer rim surface 13 d contacts the tissue surrounding the cervix103, including the intra-vaginal formix 101. The cervix 103 may beguided into the opening 11 a by the angled rim surface 13 c.

The open receiving end 12 of the present general inventive conceptallows the collar 10 to delineate the formix 101 for a cervix 103 of anylength, even when the cervix 103 extends to or past the receiving end12. Conventional devices have closed ends corresponding to the receivingend 12, As a result, when the length of the cervix 103 is greater thanthe depths of their respective cups 211 and 311, the cervix prevents therespective ends 213 and 313 from reaching the intra-vaginal formix 101.If an incision is made around the edges of the misestimating cups,vaginal shortening results. In other words, the conventional device maydelineate a portion of the vaginal wall 102, instead of the formix 100.Here, however, the collar 10 of the formix manipulator may slide up thecervix 103 to the intra-vaginal formix 101. An abnormally long cervixwill simply abut from the second opening 12 a. Thus, because the rim 13of the collar precisely locates the intra-vaginal formix 101, there isno vaginal shortening when a surgeon seeks to incise the formix 100.

Because the collar has two openings, instead of one, and because thediameter of the first opening of the collar is measured to fit thediameter of the cervix, the formix is precisely delineated and deviated.As a result, there is no vaginal shortening. The collar 10 may be chosenfrom among a plurality of collars 10 having various sizes to suit theparticular patient. The intra-vaginal formix 101 of the patient may bemeasured in advance of an operation, and a collar 10 having a rim 13corresponding to the measured size of the intra-vaginal formix 101 or adiameter corresponding to the diameter of the cervix may be used in theoperation. As a result, the rim 13 of the collar 10 is always in contactwith the formix, as opposed to the vaginal wall. The precise delineationprevents the surgeon from cutting into the vaginal wall, therebypreventing any vaginal shortening.

FIGS. 7A to 7C illustrate the angle of the rim surface 13 c with respectto a plane defined by the outer rim surface 13 d of the contact end 11.As illustrated in FIG. 7A, when the rim surface 13 c has a substantiallyflat surface, the entire rim surface 13 c may be angled with respect tothe outer rim surface 13 d at a constant angle. In other words, sincethe outer rim surface 13 d surrounds the opening 11 a to form asubstantially planar disc shape along a plane, at any given point alonga cross-section of the rim surface 13 c, a line passing throughsubstantially any two points of the rim surface 13 c will be angled atan angle θ with respect to the plane defined by the outer rim surface 13d.

In FIG. 7B, when the rim surface 13 c has a concave shape, a line Apassing through the ends of the rim surface 13 c may form an angle θwith respect to a plane defined by the outer rim surface 13 d.Similarly, as illustrated in FIG. 7C, when the rim surface 13 c has aconvex shape, a line B passing through the ends of the rim surface 13 cmay form an angle θ with respect to the plane defined by the outer rimsurface 13 d.

The angle θ may be any desired angle. For example, the angle θ may bebetween 20 degrees and 70 degrees.

When a stabilizer contains a rim surface connecting the prongs, as willbe later discussed (e.g., rim surface 25, FIG. 14B; rim surface 26 a,FIG. 17A), the stabilizer's rim surface may similarly have an angle asillustrated in FIGS. 7A to 7C.

FIGS. 8A to 8C illustrate the collar 10 or collar according to anotherembodiment of the present general inventive concept. The collar 10 mayinclude a first outer rim edge 13 a and a second outer rim edge 13 fseparated by a trough or gully 13 g. According to the embodimentillustrated in FIGS. 8A to 8C, the intra-abdominal formix 113 may belocated in the vicinity of the trough 13 g, so that as a surgeon probesthe distended intra-abdominal formix 113 from the abdominal cavity 111,the surgeon can precisely find the location of the intra-abdominalformix 113 by probing for the trough 13 g between the ridges of outerrim edges 13 a and 13 g.

The second outer rim edge 13 f may be flush with a plane defined by thefirst outer rim edge 13 a, may protrude past an end of the plane definedby the first outer rim edge 13 a, or may be recessed back from the planedefined by the first outer rim edge 13 a. The first and second outer rimedges 13 a and 13 f may have rounded or angular shapes. Similarly, thetrough 13 g may have a rounded shape or angular shape. For example, asillustrated in FIGS. 8D and 8E, the trough 13 g could have a shape of areversed triangle, having one point in the nadir of the trough, or of arectangle, having one side at the nadir of the trough.

When the rim 13 includes first and second outer rim edges 13 a and 13 f,as illustrated in FIGS. 8A to 8E, the surface of the rim 13 defining theopening 11 a may have the angled shape, as described above with respectto FIGS. 7A to 7C. For example, FIG. 8F illustrates a collar 10 having arim 13 with both first and second outer rim edges 13 a and 13 f, and anangled rim surface 13 a with respect to a plane defined by the outer rimsurface 13 d.

FIGS. 9A to 9C illustrate a stabilizer 20 according to embodiments ofthe present general inventive concept. The stabilizer 20 includes a baseportion 21 and prongs 22 extending from the base portion 21. The baseportion 21 includes walls 23 that define an opening 24 at a centerportion of the base portion. The opening 24 may be of sufficient size topass a tube or shaft, such as the shaft of the uterine manipulator 30 ofFIG. 4. As illustrated in FIGS. 9A to 9C, the stabilizer 20 may have a“V” shape similar to the stabilizer 20 a of FIG. 9A, a “U” shape similarto the stabilizer 20 b of FIG. 9B, a wishbone shape similar to thestabilizer 20 c of FIG. 9C, or any other appropriate shape.

FIGS. 10A to 10C illustrate views of the stabilizer 20 as seen from thebase 21. The stabilizer 20 may have any desired number of prongs,including two prongs (FIG. 10A), three prongs (FIG. 10B), or four prongs(FIG. 10C), or more than four prongs.

FIGS. 11A and 11B illustrate the stabilizer 20 in connection with thecollar 10. As illustrated in FIG. 11A, the prongs 22 of the stabilizer20 may be positioned within the collar 10. More particularly, the ends22 a of the prongs 22 may be positioned against the inside rim surface13 e of the collar 10. The ends 22 a may be connected to the collar 10via adhesive, welding, or any other method. Alternatively, the ends 22 amay snap into the side walls, as illustrated in FIG. 13B-13D. Accordingto yet another alternative, the ends 22 a may be held in place againstthe inside rim surface 13 e of the collar 10 only by a pressing force.That is, the stabilizer 20 and collar 10 may be separate pieces. Likethe collar, the stabilizer 20 is semi-rigid or rigid so it may maintaina pressing force against the inside rim surface 13 e of the collar 10while being compressable for removal.

The stabilizer is critical to the functioning of the collar. Morespecifically, it allows the collar to precisely delineate the formix andthereby deviate it and support it alongside the vaginal wall. Tounderstand how the stabilizer is necessary, consider what happens whenthe collar is used alone. The collar 10 is inserted via the vagina 107,and the rim 13 is positioned around the cervix 103 to receive the cervix103 through the opening 11 a. However, the collar 10 alone does notprovide sufficient force to accurately define the vaginal formix 100.Instead, a gap may be present between the outer rim surface 13 d and theformix 101. In conventional devices, this gap may result in aninaccurate estimate of the location of the formix 101 and as a resultlead to vaginal shortening or damage of nearby vital organs.

FIG. 11A illustrates the stabilizer 20 positioned within the collar 10prior to applying a force to press the collar 10 against to theintra-vaginal formix 101. Here, the ends 22 a of the stabilizer 20 maybe inserted into the insertion end 12 of the collar 10. Alternatively,the stabilizer and collar may exist as one piece. The ends may be shapedto define a circle corresponding to a circular shape of the rim 13, asexplained in FIG. 12.

FIG. 11B illustrates the stabilizer 20 positioned within the collar 10after applying the force. When the force is applied by the stabilizer 20to the inside surface 13 e of the rim 13 to press the collar 10 towardsthe formix 101, the outer surface 13 d of the rim 13 is pressed close tothe formix 101. A bulge is formed at a location corresponding to anintra-abdominal formix 113, or to the formix 100 as viewed from theabdominal cavity 111. A surgeon may then accurately estimate thelocation of the formix 100 by determining the position of the bulge.

Without the stabilizer, the collar does not precisely delineate theformix which can lead to vaginal shortening, in the best case scenario,and damage to other vital organs in the worst scenario.

In addition, the pronged design of the stabilizer in conjunction withthe dome or trapezoidal shape of the collar allows cervical accessthrough the operation. That is, a tenaculum can be inserted into thevagina alongside a uterine shaft, and may be maneuvered through theprongs and connecting to base to reach the cervix. The dome expands thevaginal wall to further increase access to the cervix.

Cervical access created by the prongs and dome also minimize the risk oftissue damage when retrieving the cervix from an operation where it isincised (e.g., a hysterectomy). Because a surgeon can attach a tenaculumto the cervix during the operation as mentioned, he may simply pull onthe tenaculum when the operation is completed to retrieve it. Theability to attach a tenaculum to the cervix eliminates the risk oftissue injury caused by blind retrieval of the cervix. In contrast,conventional devices block access to the cervix through a cup or aballoon. The formix manipulator preserves this access.

FIG. 11C illustrates the collar 10 having the two outer rim edges 13 aand 13 f being pressed against the intra-vaginal formix 101. Asillustrated in FIG. 11C, when the stabilizer 20 presses against the rimedges 13 a and 13 f of collar 10, the formix 100 distends and a bulge ofcompressed formix flesh is visible on the intra-abdominal formix 113.The gully 13 g defined by the rim edges 13 a and 13 f corresponds to thelocation of the intra-vaginal formix 101, so that a surgeon may sensethe location of the formix 100 by prodding the bulge until the gully 13g is detected.

The shape of the trough 13 g on the outside of the wall 14 of the collar10 may form an inner trough 13 h on the inside of the collar 10. Theends 22 a of the stabilizer 20 may be located within the inner trough 13h. As described above, when the rim 13 is located at the intra-vaginalformix 101, the trough 13 g may be used to guide a surgeon to make anincision at the formix 100, thereby maximizing the remaining the lengthof the remaining vaginal wall 102. In other words, by cutting tissue atthe formix 100, the amount of vaginal wall 102 remaining after a surgerymay be maximally preserved.

FIG. 12 illustrates the circle E defined by the shape of the ends 22 aof the prongs 22. The prongs 22 may have a rounded shape, and a curve ofthe ends 22 a may define a circle E having a diameter dl. While FIG. 12illustrates two ends 22 a, any number of prongs 22 may be used. Inaddition, the ends 22 a may be straight, short, or have any other shape,and the circle E may be defined by center points of the ends 22 a.

FIGS. 13A to 13C illustrate different configurations of rims 13 of thecollar 10. In FIG. 13A, the rim surface 13 c includes a protrusion 14 cthat protrudes inward toward the cavity 19 with respect to the wall 14.The protrusion 14 c may be rounded as illustrated in FIG. 13A, or mayhave an angular shape or any other appropriate shape. The protrusion 14c may form a ridge with respect to the inside of the wall 14, so thatthe ends 22 a of the prongs 22 may abut into the ridge when the prongs22 are inserted into the collar 10 from the receiving end 12.

FIG. 13B illustrates a ridge 14 d having a hook shape, so that the ridge14 d surrounds the entire end 22 a of the prongs 22 when the prongs 22are inserted into the crook defined by the ridge 14 d. This allows theprongs to snap into the rim.

FIG. 13C illustrates the stabilizer 20 inserted into the collar 10. Thestabilizer 20 is inserted, prong-first, into the collar 10 and the ends22 a of the prongs 22 press against the ridge 14 c. Consequently, whenforce is applied to the stabilizer 20, the stabilizer 20 may transferthe force to the rim 13 of the collar 10.

FIG. 13D illustrates the hook-shaped ridge 14 d having a protrusion tointerlock with a protrusion 22 b at an end 22 a of the prongs 22. Thismay allow the prongs 22 to be attached to the collar 10 by snapping intoplace temporarily or permanently. Alternatively, the ridge 14 d mayinclude a recess to receive a protrusion from the prongs 22.

FIGS. 14A and 14B illustrate a stabilizer 20 having a rim 25 at the ends22 a of the prongs 22. The rim 25 may have a substantially flat surfaceor a rounded surface. The rim 25 may connect each of the prongs 22 andmay have a substantially circular shape to correspond to the shape ofthe opening of the collar 10 and fit underneath the rim 13 of the collar10. When the stabilizer 20 is pushed against the collar 10, the rim 25distributes the force of the prongs 22 evenly against the rim 13 ofcollar 10, thereby creating more even pressure around the intra-vaginalformix 101. Evenly distributed pressure around the intra-vaginal formix101 creates a more evenly distributed bulge of distended formix fleshvisible at the intra-abdominal formix 113. As illustrated in FIG. 14B,the rim 25 may have an outer rim portion 25 a to extend past an outersurface of the prongs 22. The outer circumference of the outer rimportion 25 a may conform to an inner circumference of the inside wall ofthe collar 10.

The rim 25 may be formed of semi-rigid or rigid material. The materialmay be semi-rigid to allow compression when removing the device from thevaginal canal after the medical procedure.

FIGS. 15A to 15D illustrate the rim 25 having different locations withrespect to the prongs 22. As illustrated in FIG. 15A, the rim 25 mayhave a width d7 greater than the width d8 of the prong 22, where theprong 22 contacts the rim 25. The inside edge 25 a of the rim 25 may beflush with an inside surface 22 b of the prong 22 as illustrated in FIG.15A. Alternatively, the inside edge 25 a and the outside edge 25 b ofthe rim 25 may each extend past the inside surface 22 b and outsidesurface 22 c, respectively of the prong 22, as illustrated in FIG. 15B.Alternatively, the outside edge 25 b of the rim 25 may be flush with theoutside surface 22 c of the prong 22 and the inside edge 25 a of the rim25 may extend past the inside surface 22 b of the prong 22, asillustrated in FIG. 15C.

According to yet another alternative, as illustrated in FIG. 15D, theprongs 22 and the rim 25 may have a same width, so that the inside andoutside edges 25 a and 25 b of the rim 25 are each flush with therespective inside and outside surfaces 22 b and 22 c of the prong 22.

FIG. 16 illustrates the stabilizer 20 positioned within the collar 10.The rim 25 of the stabilizer 20 may press against the inside rim surface13 e of the collar 10. The rim 25 may be fixed to the collar 10, such aswith adhesive, welding, or any other bonding method. Alternatively, therim 25 may not be bonded to the collar 10, and may maintain a positionwith respect to the collar 10 only by a pressing force against theinside rim surface 13 e of the collar 10.

FIGS. 17A to 17D illustrate a stabilizer 20 according to anotherembodiment of the present general inventive concept. The stabilizer 20may include a rim 26 connected to the prongs 22. The rim 26 includes anouter edge 26 b and an inner edge 26 a. The inner edge 26 a is locatedinward from the outer edge 26 b in a radial direction, and outward fromthe outer edge 26 in a linear direction with respect to the base 21 ofthe stabilizer 20. In other words, the inner edge 26 a is offset in aninward direction from the outer edge 26 b by a distance d9; and theinner edge 26 a is offset in a linear direction from the outer edge 26 bwith respect to the base 21 by a distance d10. A surface 26 c spansbetween the inner edge 26 a and the outer edge 26 b. According to oneembodiment of the general inventive concept, the surface 16 c has aconcave shape.

As illustrated in FIG. 17B, when the stabilizer 20 is positioned withinthe collar 10, the inner edge 26 a may be offset from the rim 13 of thecollar 10.

As illustrated in FIG. 17C, the inner edge 26 a of the rim 26 may passthrough the opening 11 a of the contact end 11 of the collar 10. Theinner edge 26 a may extend past the rim 13 of the collar 10 by adistance d11 in a linear direction with respect to the base 21. Inaddition, the inner edge 26 a may be offset from the outer edge 13 a ofthe collar 10 by a distance d12 in a radial direction. A trough 27 maybe formed between the inner edge 26 a of the rim 26 and the outer edge13 a of the rim 13 of the collar 10. The trough 27 may be pressedagainst the intra-vaginal formix 101, such that a surgeon may locate thevaginal formix 100 by detecting the location of the trough 27. In otherwords, the trough 27 formed by the combination of the collar 10 andstabilizer 20 of FIGS. 17A to 17D may act in a manner similar to thetrough 13 g, described above with respect to FIGS. 8A to 8C.

As illustrated in FIG. 17D, the outer edge 13 a of the rim 13 of thecollar 10 may be substantially flush with the inner edge 26 a of the rim26 of the stabilizer 20. The outer edge 26 b of the rim 26 of thestabilizer 20 may contact an inside surface of the wall 14 of the collarto form an offset distance d12 in a radial direction between the insideedge 26 a of the rim 26 and the outside edge 13 a of the rim 13 of thecollar 10. The distance d12 between the edges 26 a and 13 a may define atrough 27 to indicate to a surgeon the location of the formix 100, asdescribed above.

The rim 26 may be formed of a rigid to semi-rigid material. The rim 26and the stabilizer 20 may be fixed to the collar 10 by bonding,latching, sliding, adhesive, welding, or by any other means.Alternatively, the stabilizer 20 may not be fixed with respect to thecollar 10, and may be freely removable from the collar 10.

FIGS. 18A and 18B illustrate a strap 64 connected to the collar 10according to embodiments of the present general inventive concept. Asillustrated in FIG. 18A, the collar 10 may include a ring 15, tab, orother protrusion fixed to the collar 10 to which a strap 64 may beattached. The ring 15 may be welded, adhered to, for formed integrallywith the wall 14 of the collar 10. When an operation is completed, orwhen a surgeon desires to remove the collar 10, the surgeon may pull onthe strap, and the collar 10 may easily slide down vaginal canal and beremoved from a patient's body.

As illustrated in FIG. 18B, a hole 14 e may be formed in the collar 10,and the strap 64 may be fixed to the collar 10 by way of the hole 14 e.The hole 14 e may be located anywhere on the collar.

The strap connected to the first opening of the dome-shaped collarminimizes the risk of tissue injury caused by device retrieval. Thesurgeon does not have to fish for the device. In addition, when thestrap is placed near the contact end 11, the device may be exit thevaginal canal without damaging the vaginal opening. This is because thecontact end 11 has a smaller diameter than the receiving end. So whenthe strap is pulled out of the vaginal canal, the smaller contact end 22is likely to exit first. This permits vaginal opening to expand to theincreasing diameter of the receiving end 12. The alternative, pullingout the receiving end 12 first may damage the tissue if it has adiameter larger than the vaginal opening.

FIG. 19 illustrates the stabilizer 20 and the collar 10 attached to theinner shaft 31 of the uterine manipulator 30. A pressing portion 60including an outer tube 61, a fixing portion 62, and a screw 63 may alsobe mounted to the uterine manipulator 30. A handle 32 may be connectedto the end of the shaft 31. The handle 32 may include, for example, acontrol part including an inspection port and controls to move theballoon 35 upward, downward, and sideward, and to inflate and deflatethe balloon 35.

The outer tube 61 of the pressing portion 60 may be pressed against thestabilizer 20. The pressing causes the prongs 22 of the stabilizer 20 toand push against rim 13 of collar 10, which causes the rim 13 to pressagainst the intra-vaginal formix 101 and distend the formix. When thepressing portion 60 is moved a desired distance along the shaft 31 togenerate a desired force, the screw 63 which is mounted to the fixingportion 62 may be tightened to the shaft 31 to fix the pressing portion60 with respect to the shaft 31.

A strap 64 may be connected between the fixing portion 62 and the collar10 to allow easy removal of the collar 10 along with the uterinemanipulator 30. The collar 10 may include a hole 14 e and the strap 64may be connected to the hole 14 e via a ring, a tie, or any other means.

To prevent the tissue of the vaginal canal from moving with respect tothe collar 10, the collar 10 may include ridges, as illustrated in FIGS.20A and 20B. Ridges 16 may be formed on the body of the wall 14. Inaddition, the collar 10 may include an additional ridge 17 at thereceiving end 17 of the collar 10.

The ridges 16 and 17 may prevent the tissue from retracting from thecontact end 11 of the collar 10 toward the receiving end 12 when theformix at the rim 13 is cut. The ridges 16 and 17 may engage and gripthe tissue to prevent it from retracting. The ridge 17 at the receivingend 12 may be larger than the ridges 16 on the body of the collar 10 sothat even if the tissue is able to slide past the smaller ridges 16, thelarger ridge 17 may prevent the tissue from sliding past the receivingend 12 of the collar 10.

Ridges 16 and 17 coupled with the dome shaped collar 10 minimizeabdominal disinflation. The increasing diameter of the collar 10 makesit difficult for the tissue to retract from the contact end 11 to thereceiving end 12. Likewise, the ridges 16 and 17 may prevent tissue fromsliding. As a result, a seal may be formed between tissue of the vaginalwall 102 and the collar 10 even after the formix is incised.

The ridges 16 and 17 may be made of the same material as the collar 10or of another material applied to the collar 10 after the collar 10 isfabricated. The ridges 16 and 17 may have rough surfaces relative to theoutside surface of the collar 10. The ridges 16 and 17 may be concentriccircles parallel to each other. The ridges may be broken circles havinggaps between raised portions, or unbroken circles.

As described above, a formix manipulator according to the presentgeneral inventive concept accurately delineates, deviates and supportsthe vaginal formix even when a shape and/or size of a cervix may beunusual. Its dome shape and ridges maintain a seal in the abdominalcavity even after an incision is made in the vaginal formix or vaginalwall. In addition, the dome shape allows for precise delineation;provides a platform for the dissection of organs adjacent to the vaginalwall; expands the vaginal wall for maximal cervical access; and itsincreasing diameter minimizes the risk of injury during device insertionand retrieval if attached to a strap. The manipulator's open-endedcollar in combination with the stabilizer preserve access to the cervixthrough the operation, allowing a surgeon to attach tenaculums to thecervix to avoid blind cervix retrieval and tissue damage. In addition,the stabilizer also allows for precise formix delineation by pressingthe rim of the collar to the formix. This maximizes delineation,deviation, support, while also minimizing the risk of vaginal shorteningand injury to other vital organs. In addition, the formix manipulatorprovides an accurate guide for a surgeon to make an incision byproviding a gully at a location of the vaginal formix. Other featuresand/or utilities of the present general inventive concept would beapparent to one having ordinary skill in the art and are not limited tothe above-described features and/or utilities.

Although a few embodiments of the present general inventive concept havebeen shown and described, it would be appreciated by those skilled inthe art that changes may be made in these embodiments without departingfrom the principles and spirit of the general inventive concept, thescope of which is defined in the claims and their equivalents.

What is claimed is:
 1. A fornix manipulator, comprising: a collar havinga first end and a second end having a diameter greater than the firstend, the first end having a first opening adapted to receive a cervixinto the collar and a rim to encircle the first opening, and the secondend having a second opening, the collar having an inner surface andouter surface, wherein the outer surface is adapted to contact a vaginalwall; and a stabilizer comprising a base portion and a plurality ofprongs adapted to extend from the base portion to couple to the collarwherein the rim comprises: (a) a first outer rim edge adjacent to thefirst opening and having a first rim diameter; and (b) a second outerrim edge having a second rim diameter and being separated from the firstouter rim edge by a first gully; the first rim diameter being less thanthe second rim diameter; wherein the prongs are adapted to contact asecond gully on the inner surface between the second outer rim edge andcollar wall.
 2. The fornix manipulator of claim 1, wherein the collarhas one of a trapezoid cross-section shape, a domed cross-section shape,or a combination of a trapezoid and domed cross-section shape.
 3. Thefornix manipulator of claim 1, wherein the collar has a plurality ofparallel ridges around an outer surface of the collar.
 4. The fornixmanipulator of claim 1, wherein the collar has one of a hole, ring, tab,or other protrusion fixed to the collar to receive a strap.
 5. Thefornix manipulator of claim 1 comprising a shaft, wherein the baseportion of the stabilizer has a guide hole adapted to couple to theshaft.
 6. The fornix manipulator of claim 1, wherein the rim includes aprotrusion extending inward toward a middle portion of the collar fromthe first end.
 7. The fornix manipulator of claim 1, wherein the prongsare adapted to contact the inner surface, which is adapted to contactthe cervix.
 8. The fornix manipulator of claim 1, wherein the prongs ofthe stabilizer are configured to contact an additional rim on thecollar.
 9. The fornix manipulator of claim 1, wherein the stabilizerincludes a stabilizer rim connecting ends of the prongs that areopposite the base portion.
 10. The fornix manipulator of claim 9,wherein the stabilizer rim is adapted to contact the inner surface ofthe collar.
 11. The fornix manipulator of claim 10, wherein thestabilizer rim is adapted to contact an additional rim included on thecollar.
 12. The fornix manipulator of claim 10, wherein the stabilizerrim is adapted to contact the second gully.
 13. The fornix manipulatorof claim 9, wherein the stabilizer rim includes an outer edge, an inneredge, and a rim surface between the outer edge and the inner edge todefine the opening, and the rim surface is angled with respect to aplane defined by the outer edge.
 14. A fornix manipulator comprising: acollar having a first end and a second end having a diameter greaterthan the first end, the first end having a first opening adapted toreceive a cervix into the collar and a rim to encircle the firstopening, and the second end having a second opening, the collar havingan inner surface and outer surface, wherein the outer surface is adaptedto contact a vaginal wall; and a stabilizer comprising a base portionand a plurality of prongs adapted to extend from the base portion tocouple to the collar; wherein the stabilizer includes a stabilizer rimconnecting the ends of the prongs that are opposite the base portion;wherein the stabilizer rim includes an inner edge, an outer edge that iscloser than the inner edge to the base portion in a linear direction andfarther from a center of the stabilizer in a radial direction than theinner edge, and an outer rim surface that connects the inner edge to theouter edge.
 15. The fornix manipulator of claim 14, wherein a diameterof the inner edge of the stabilizer rim is smaller than a diameter ofthe collar rim, such that a gap is located between the inner edge of thestabilizer rim and the collar rim when the outer edge of the stabilizeris in contact with the inner surface of the first end of the collar. 16.The fornix manipulator of claim 14, wherein the inner edge of thestabilizer rim extends past the collar rim in a linear direction whenthe outer edge of the stabilizer is in contact with the inner surface ofthe first end of the collar.
 17. The fornix manipulator of claim 14,wherein the inner edge of the stabilizer rim is flush with the collarrim when the outer edge of the stabilizer is in contact with the innersurface of the first end of the collar.
 18. A fornix manipulatorcomprising: a collar having (a)(i) a first end and a second end with adiameter greater than the first end, the first end having a firstopening encircled by a rim, and the second end having a second opening,and (a)(ii) an inner surface adapted to contact a cervix and an outersurface adapted to contact a vaginal wall; wherein the first and secondopenings form opposing ends of a hollow tunnel adapted to receive thecervix; and a stabilizer having (b)(i) a base portion, which has a firststabilizing end, and (b)(ii) a second stabilizing end greater indiameter than the first stabilizing end, the first stabilizing endhaving a guide hole adapted to couple to a shaft and the secondstabilizing end having a stabilizer rim adapted to couple to the collar;wherein the stabilizer includes at least one window between thestabilizer rim and the base portion and between two or more prongs thatcouple the base portion to the stabilizer rim.
 19. The fornixmanipulator of claim 18 comprising ridges around the outer surface thatare parallel to the first end.
 20. The fornix manipulator of claim 18,wherein the tunnel includes no openings other than the first and secondopenings.
 21. The fornix manipulator of claim 20, wherein the tunnelincludes an inner surface portion that has a trapezoidal shapedcross-section.
 22. The fornix manipulator of claim 18 wherein the two ormore prongs are adapted to extend from the base portion to stabilize thestabilizer rim.
 23. The fornix manipulator of claim 18, wherein the rimcomprises: a first outer rim edge adjacent to the first opening andhaving a first rim diameter; and a second outer rim edge having a secondrim diameter and being separated from the first outer rim edge by agully; wherein the first rim diameter is less than the second rimdiameter; wherein when the stabilizer is fully coupled to the collar andthe gully does not directly contact the stabilizer.
 24. The fornixmanipulator of claim 18, wherein the stabilizer rim has a diameter lessthan a diameter of the second opening.
 25. The fornix manipulator ofclaim 24, wherein the stabilizer rim is adapted to contact the innersurface.
 26. The fornix manipulator of claim 25, wherein the stabilizerrim is adapted to contact an additional rim on the inner surface. 27.The fornix manipulator of claim 18, wherein the second opening isencircled by a second rim.
 28. The fornix manipulator of claim 18,wherein the stabilizer is detachable from the collar.